2014 Questionnaire to identify influenza vaccine, diagnostic and pharmaceutical manufacturers using WHO Global Influenza Surveillance and Response System (GISRS) under Section 6.14.3 of the PIP Framework
The Pandemic Influenza Preparedness (PIP) Framework is an international framework that was approved in May 2011 by the 194 countries of the World Health Organization (WHO). The PIP Framework brings together many stakeholders that work together to ensure that the world is better prepared to respond to the next influenza pandemic. To that end, the Framework establishes a PIP Benefit Sharing System, that operates to, inter alia, provide to all countries pandemic influenza surveillance and risk assessment and early warning information, and build relevant capacities in countries where needs are identified.
Global Influenza Surveillance and Response System (GISRS)
For more than 60 years, WHO has coordinated the Global Influenza Surveillance and Response System (GISRS), an international network of public health laboratories that conduct global, year-round virological surveillance to assess epidemic and pandemic risks posed by influenza viruses. GISRS currently comprises six WHO Collaborating Centres (CCs), four WHO Essential Regulatory Laboratories (ERLs), twelve H5 Reference Laboratories and 141 National Influenza Centres (NICs) covering 111 countries in the world. GISRS contributes to the bi-annual Influenza Vaccine Composition recommendations made by WHO. GISRS laboratories produce significant influenza risk assessment information (virological and epidemiological), genetic sequence data, virus susceptibility analyses, and physical materials such as candidate vaccine viruses and potency testing reagents – all of which are provided and distributed to laboratories and interested parties around the world, for the most part free of charge.
The Partnership Contribution (PC) is one element of the PIP Benefit Sharing System. It is an annual payment, made to WHO by "Influenza vaccine, diagnostic and pharmaceutical manufacturers using the WHO Global Influenza Surveillance and Response System (GISRS)". Amounts to be paid by individual manufacturers are to be based on principles of transparency and equity, and on their nature and capacities (see PIP Framework, section 6.14.3). The Framework defines "influenza vaccine, diagnostic and pharmaceutical manufacturers" as:
- public or private entities including academic institutions, government owned or government subsidized entities, non-profit organizations or commercial entities;
- which develop and/or produce human influenza vaccines or other products derived from or using H5N1 or other influenza viruses of human pandemic potential" (see Framework, section 4.3).
Consistent with the Framework, WHO uses the funds provided under the PC to strengthen influenza pandemic preparedness and response capacities in countries that require such support.
In 2012 and 2013 a similar Questionnaire was published by WHO. Following receipt of several comments, WHO has modified and/or expanded some of the questions to address concerns regarding the meaning of the terms “manufacturer” and “use of GISRS”.
The 194 countries that constitute the Member States of WHO, established the Partnership Contribution “with a view to ensuring the sustainable financing of the PIP Benefit Sharing System […]” (see PIP Framework, section 6.14.1). In directing that payment of the annual Partnership Contribution be made by “…manufacturers using GISRS”, WHO Member States intentionally sought to capture the broadest group of manufacturers possible, irrespective of corporate structures or their level of use of GISRS. The objective was to ensure that all manufacturers (as defined in PIP Framework Section 4.3) who use GISRS, participate in some manner in the Partnership Contribution. The PIP Framework therefore contains a broad definition of “manufacturers” which covers public or privates entities, and includes academic institutions, government owned or subsidized entities, non-profit organizations or commercial entities.
With the aim of identifying as many contributors as possible, the following changes are being made to the questions in this year’s Questionnaire:
- The term “manufacturer” has been revised to clarify that it covers entities controlled by a manufacturer, e.g. subsidiaries, affiliates, associates, ventures, concerns, corporations, partners, divisions, branches, holdings, departments, etc.
- The concept of “use of GISRS” has been clarified by providing examples.
Additionally, to increase the potential group of contributors, and assist WHO in better understanding the range of entities that use GISRS, all non-GISRS recipients of PIP Biological Material (PIP BM) recorded in the Influenza Virus Traceability Mechanism (IVTM) will be sent the Questionnaire to complete.